The U.S. Food and Drug Administration (FDA) has issued draft guidance outlining information that should be included in pre-market submissions to demonstrate electromagnetic compatibility (EMC) for electrically powered medical devices and medical devices with electrical or electronic functions.

This draft guidance, Electromagnetic Compatibility (EMC) of Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff, is not for implementation at this time. It will be open for public comments for 60 days at under docket number FDA-2015-D-3787.

Read the Draft Guidance